Instructions Ronocyte solution for injection 1000 mg/4 ml ampoule 4 ml No. 5
Composition
active ingredient: citicoline;
1 ampoule (4 ml) of solution contains citicoline (in the form of citicoline sodium) 500 mg or 1000 mg;
Excipients: sodium hydroxide or hydrochloric acid, water for injections.
Dosage form
Solution for injection.
Main physicochemical properties: transparent colorless or yellowish solution.
Pharmacotherapeutic group
Psychostimulants and nootropics.
ATX code N06B X06.
Pharmacological properties
Pharmacodynamics
Citicoline stimulates the biosynthesis of structural phospholipids of neuronal membranes, which is confirmed by magnetic resonance spectroscopy. Citicoline improves the functioning of such membrane mechanisms as ion pumps and receptors, without the regulation of which normal conduction of nerve impulses is impossible. Due to its stabilizing effect on the neuronal membrane, citicoline exhibits anti-edematous properties that contribute to the reabsorption of brain edema.
Experimental studies have shown that citicoline inhibits the activation of certain phospholipases (A1, A2, C, and D), reducing the formation of free radicals, preventing the destruction of membrane systems, and preserving antioxidant defense systems such as glutathione.
Citicoline preserves neuronal energy reserves, inhibits apoptosis, and stimulates acetylcholine synthesis.
It has been experimentally proven that citicoline also exhibits a preventive neuroprotective effect in focal cerebral ischemia.
Citicoline has been reported to significantly increase functional recovery in patients with acute stroke, which is consistent with a slowing of the growth of ischemic brain lesions as measured by neuroimaging. In patients with traumatic brain injury, citicoline accelerates recovery and reduces the duration and severity of post-traumatic stress disorder.
Citicoline improves the level of attention and consciousness, helps reduce the manifestations of amnesia, cognitive and neurological disorders associated with cerebral ischemia.
Pharmacokinetics
Citicoline is well absorbed after oral, intramuscular and intravenous administration. Plasma choline levels increase significantly after administration by the above routes. Absorption after oral administration is almost complete, and the bioavailability is almost the same as after intravenous administration.
Depending on the route of administration, the drug is metabolized in the intestine, liver to choline and cytidine. After administration, citicoline is widely distributed in brain structures with rapid incorporation of the choline fraction into structural phospholipids and the cytidine fraction into cytidine nucleotides and nucleic acids. Having reached the brain, citicoline is incorporated into cellular, cytoplasmic and mitochondrial membranes, participating in the construction of the phospholipid fraction.
Only a small amount of the dose is found in the urine and feces (less than 3%). Approximately 12% of the dose is excreted in exhaled CO2. There are two phases in the excretion of the drug in the urine: the first phase - approximately 36 hours - in which the rate of excretion decreases rapidly, and the second phase in which the rate of excretion decreases much more slowly. The same phasic nature is observed in the excretion of CO2, the rate of excretion of exhaled CO2 decreases rapidly after about 15 hours, then it decreases much more slowly.
Indication
· Stroke, acute phase of cerebrovascular disorders and treatment of complications and consequences of cerebrovascular disorders.
· Traumatic brain injury and its neurological complications.
· Cognitive and behavioral disorders due to chronic vascular and degenerative cerebral disorders.
Contraindication
Hypersensitivity to any component of the drug. Increased tone of the parasympathetic nervous system.
Interaction with other medicinal products and other types of interactions
The drug should not be used simultaneously with drugs containing meclofenoxate. Enhances the effect of levodopa.
Application features
In case of persistent intracranial bleeding, it is recommended to administer the drug as a very slow intravenous infusion (30 drops per minute) and not to exceed a daily dose of 1000 mg.
Use during pregnancy or breastfeeding
There are no adequate data on the use of citicoline in pregnant women. The drug should be used during pregnancy and breastfeeding only if the expected benefit to the woman outweighs the possible risk to the fetus or child.
There is no data on the penetration of citicoline into breast milk.
Ability to influence reaction speed when driving vehicles or other mechanisms
Citicoline does not affect the ability to drive vehicles and operate complex mechanisms.
Method of administration and doses
The recommended dose for adults is 500-2000 mg per day, depending on the severity of the patient's condition.
The maximum daily dose is 2000 mg.
In acute and emergency conditions, the maximum therapeutic effect is achieved when the drug is administered in the first 24 hours.
The duration of treatment depends on the course of the disease and is determined by the doctor.
No dose adjustment is necessary for elderly patients.
The drug is compatible with all intravenous isotonic solutions, as well as with hypertonic glucose solutions.
This solution is for single use only. The solution should be administered immediately after opening the ampoule. Any unused solution should be discarded.
If treatment is necessary, continue to use citicoline in the form of a solution for oral administration.
Children
There is insufficient data on the use of the drug in children.
Overdose
Unknown.
Given the low toxicity of the drug, the likelihood of poisoning is low, even if therapeutic doses are accidentally exceeded.
Adverse reactions
Very rare (< 1/10,000) (including patient reports).
From the side of the central and peripheral nervous system: severe headache, vertigo, hallucinations.
From the cardiovascular system: arterial hypertension, arterial hypotension, tachycardia.
Respiratory system: shortness of breath.
On the part of the digestive system: nausea, vomiting, diarrhea.
Skin: hyperemia, allergic rash, exanthema, purpura, urticaria, itching, angioedema, anaphylactic shock.
General reactions: chills, swelling, changes at the injection site.
Expiration date
5 years.
Storage conditions
Store at a temperature not exceeding 25 ºС in a place inaccessible to children.
Incompatibility.
Do not use solvents not listed in the “Method of administration and dosage” section.
Packaging
4 ml of solution in a glass ampoule; 5 ampoules in a contour blister pack; 1 contour blister pack in a cardboard box.
Vacation category
According to the recipe.
Producer
K.O. Rompharm Company SRL, Romania / SC Rompharm Company SRL, Romania.
Location of the manufacturer and its business address
Otopeni city, Eroilor str. № 1A, 075100, jud. Ilfov.
Applicant
WORLD MEDICINE LTD / WORLD MEDICINE LTD.
